Adopting A Risk Based Approach

Validation

A properly designed system will assure that every step, process, and change has been evaluated before its implementation.

Health Canada, FDA and other regulatory agency refer to Pharmaceutical validation on the purpose of establishing documented evidence that a process or system, when operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its pre-determined specifications and quality attribute.

A properly designed system will provide a high degree of assurance that every step, process, and change has been properly evaluated before its implementation. Testing a sample of a final product is not considered sufficient evidence that every product within a batch meets the required specification. The Validation Master Plan is the document that describes how and when the validation program will be executed in a facility.

The Cannabis Compliance Inc. validation team has helped customers by adopting a risk-based approach throughout the lifecycle of the quality system taking into account patient safety, data integrity and product quality. Above approach will also support clients on regulatory compliance and the confidence that their overall quality system in place are validated.